Home NDC 51206-312 Opal by Opalescence Original
Product NDC 51206-312
11-digit product format 512060312
Labeler code 51206
Product ID 51206-312_5b14e96f-d015-5738-e063-6294a90ac014
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form GEL, DENTIFRICE
Route DENTAL
Labeler Ultradent Products, Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-11-19
Marketing end 2029-02-21
Substance SODIUM FLUORIDE
Active strength 1.1 mg/g
NDC exclude flag No
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Opal by Opalescence Original Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 1.1 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1044547 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51206-312-01 Opal by Opalescence Original 1 in 1 CARTON GEL, DENTIFRICE 1 5 51206-312-01 Opal by Opalescence Original 133 g in 1 TUBE GEL, DENTIFRICE 133 5 51206-312-02 Opal by Opalescence Original 1 in 1 CARTON GEL, DENTIFRICE 1 5 51206-312-02 Opal by Opalescence Original 3 in 1 PACKAGE, COMBINATION GEL, DENTIFRICE 3 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51206-312 OPAL BY OPALESCENCE ORIGINAL (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 4 Current NDC, 4 package rows 20250402_5c3bf8fc-2e8f-4a58-bcbf-e47540072a49.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 36 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cloveden Sensitive Care Tooth SODIUM FLUORIDE DONG IL PHARMS CO.,LTD 3fb153f1-ba6e-7251-e063-6294a90abe62 2025-09-26 Warnings Exact identifier application number: M021 Cloveden 100 times higher concentrated CETYLPYRIDINIUM CHLORIDE DONG IL PHARMS CO.,LTD 3fb1a2ee-381e-a9e8-e063-6394a90a864b 2025-09-26 Warnings Exact identifier application number: M021 unpa Cha Cha Toothpaste SODIUM MONOFLUOROPHOSPHATE Lycl Inc. 230b3cf2-053a-4e8b-8d50-05bbc877faa8 2025-09-25 Warnings Exact identifier application number: M021 TheraBreath Anticavity SODIUM FLUORIDE Church & Dwight Co., Inc. 3c5d58f1-ea8c-4708-bbc6-21e1cd1446da 2025-09-19 Warnings Exact identifier application number: M021 Optimax Professional Whitening Anticavity Fluoride SODIUM MONOFLUOROPHOSPHATE WHITE GLO USA INC 8c4b9db9-8f23-4dd5-ab6e-1c2f9a3da5b1 2025-09-18 Warnings Exact identifier application number: M021 Optimax Professional Whitening Anticavity Fluoride SODIUM MONOFLUOROPHOSPHATE WHITE GLO USA INC c1bbdd36-53fb-43a3-ba20-afbeb6359d31 2025-09-18 Warnings Exact identifier application number: M021 Brush Buddies Cookies n Cream Ice Cream FLAVORED Anticavity Fluoride SODIUM FLUORIDE Ashtel Studios, Inc. f70d378b-d4d6-454c-90a9-794459960c8c 2025-09-17 Warnings Exact identifier application number: M021 Brush Buddies Chocolate Ice Cream FLAVORED Anticavity Fluoride SODIUM FLUORIDE Ashtel Studios, Inc. 26b9b2dd-7cb2-47c3-8bbb-94a48f02dd21 2025-09-16 Warnings Exact identifier application number: M021 Brush Buddies Mint Chocolate Chip Ice Cream FLAVORED Anticavity Fluoride SODIUM FLUORIDE Ashtel Studios, Inc. 3436532d-e078-4dbb-a823-b4542e961534 2025-09-16 Warnings Exact identifier application number: M021 Colgate Total Plaque Pro Release Fresh Mint STANNOUS FLUORIDE Colgate-Palmolive Company 9b1671c4-8680-6e2a-9f10-0400840ca5a9 2025-09-12 Warnings Exact identifier application number: M021 Colgate Total Plaque Pro Release Whitening STANNOUS FLUORIDE Colgate-Palmolive Company ddc09ce5-181a-1b50-7094-314bb58a15cf 2025-09-12 Warnings Exact identifier application number: M021 Cavity Protection Fresh Mint Anticavity Mouthwash SODIUM FLUORIDE Oxyfresh Worldwide Inc 3efc66b2-fcf9-4d26-9cdd-1af8225312b4 2025-09-10 Warnings Exact identifier application number: M021 CLOSE UP Freshening with Mouthwash SODIUM FLUORIDE Church & Dwight Co., Inc. e660b0d7-4cc5-4028-bdf5-016b85899728 2025-09-09 Warnings Exact identifier application number: M021 Essentials Healthy Teeth and Gums SODIUM FLUORIDE 0.24% Church & Dwight Co., Inc. 9652c004-6b47-840f-e053-2995a90a6e98 2025-09-09 Warnings Exact identifier application number: M021 Complete Care Whole Mouth Protection SODIUM FLUORIDE Church & Dwight Co., Inc. d00f9d16-de0e-4ffc-e053-2a95a90a2069 2025-09-09 Warnings Exact identifier application number: M021 Brush Buddies Vanilla Ice Cream FLAVORED Anticavity Fluoride SODIUM FLUORIDE Ashtel Studios, Inc. e911effb-d59f-4054-9501-803b64369ab4 2025-09-05 Warnings Exact identifier application number: M021 The Simpsons Purple Squishee Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 3de10638-1a39-b747-e063-6294a90a4ca5 2025-09-03 Warnings Exact identifier application number: M021 Optimax Purple Anticavity Fluoride SODIUM MONOFLUOROPHOSPHATE WHITE GLO USA INC 8264e849-a6b3-4953-a85b-da9d4e7f5a70 2025-09-02 Warnings Exact identifier application number: M021 CAREKON ANTI-CAVITY FLUORIDE SODIUM MONOFLUOROPHOSPHATE Hunan Yinhuatang Pharmaceutical Technology Co., Ltd. 3baca3b6-ff48-0579-e063-6394a90abd08 2025-08-29 Warnings Exact identifier application number: M021 Brush Buddies 2 VALUE PACK CAVITY PROTECTION ANTI-CAVITY FLUORIDE SODIUM MONOFLUOROPHOSPHATE Ashtel Studios, Inc. fc794fe5-7135-4b2b-b002-a75908223f20 2025-08-13 Warnings Exact identifier application number: M021
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51206-312-01 51206031201 1 TUBE in 1 CARTON (51206-312-01) / 133 g in 1 TUBE 1 tube 2023-11-19 2029-02-21 No No Historical 51206-312-02 51206031202 3 CARTON in 1 PACKAGE, COMBINATION (51206-312-02) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE 3 carton 2023-11-19 2029-02-21 No No Historical